GB-5001 for Alzheimer's Disease

Syneos Health, Québec, Canada
Alzheimer's DiseaseGB-5001 - Drug
Eligibility

Study Summary

This trial tests the safety and effectiveness of a new medicine for healthy male volunteers. Results will help predict how the drug works in multiple doses.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

5 Primary · 1 Secondary · Reporting Duration: Day 64

Day 64
Electrocardiograms
Incidence, severity, and dose-relationship of AEs
Injection site assessments
Key PK parameters for single dose IM and Oral cohorts
Physical examination
Vital signs

Trial Safety

Phase-Based Safety

1 of 3

Trial Design

3 Treatment Groups

Oral cohort
1 of 3
GB-5001
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

48 Total Participants · 3 Treatment Groups

Primary Treatment: GB-5001 · Has Placebo Group · Phase 1

GB-5001
Drug
Experimental Group · 1 Intervention: GB-5001 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Oral cohort
Drug
ActiveComparator Group · 1 Intervention: Oral cohort · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 64

Who is running the clinical trial?

G2GBio, Inc.Lead Sponsor

Eligibility Criteria

Age 18 - 55 · Male Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your blood pressure should be between 95-140 mmHg (systolic) and 55-90 mmHg (diastolic) and your heart rate should be between 60-100 beats per minute. However, the study doctor may make exceptions.

Frequently Asked Questions

Is it permissible for me to join this clinical investigation?

"Those suffering from Alzheimer's and between the ages of 18 to 55 may be eligible for this trial. We are seeking approximately 48 participants in total." - Anonymous Online Contributor

Unverified Answer

What is the aggregate of participants signing up for this experiment?

"Correct. According to the clinicaltrials.gov website, this medical trial is currently seeking participants after being first published on August 26th 2022 and updated recently on November 9th 2022. The research requires 48 patients from a single site for successful completion." - Anonymous Online Contributor

Unverified Answer

Are octogenarians allowed to partake in this research trial?

"This trial only accepts applicants aged between 18 and 55. For younger individuals, there are 23 trials available and for those over 65, 536 opportunities exist." - Anonymous Online Contributor

Unverified Answer

Is there still an opportunity for individuals to participate in this research?

"According to the clinicaltrials.gov data, this trial is in a state of active recruitment since its initial posting on August 26th 2022 and subsequent update on November 9th 2022." - Anonymous Online Contributor

Unverified Answer

What potential risks do patients face when administered GB-5001?

"As this is an early stage trial, the safety of GB-5001 was assessed to be a 1 on our rating scale. This grade reflects limited data supporting efficacy and only preliminary evidence indicating its safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.